Thursday, April 30, 2009

A number of anti-smoking advocates have been issuing personal attacks against the ethics and character of New York Senator Kirsten Gillibrand, accusing her of professional misconduct as an attorney by virtue of her having represented Philip Morris while she was an associate at the law firm of Davis, Polk, & Wardwell. Because she represented tobacco company defendants in court cases and because they allege that she was guilty of professional misconduct, anti-smoking advocates have called Gillibrand a "sellout."

For example, Cliff Douglas - the executive director of the University of Michigan Tobacco Research Network - has written two pieces which attack Gillibrand's ethical conduct (commentary #1; commentary #2).

In this post, I analyze the evidence that has been presented in support of the allegation that Gillibrand is guilty of professional misconduct and conclude that the accusation is based on guilt by association, not on appropriate evidence that would warrant such a personal attack.

The Evidence

Based on a paragraph by paragraph analysis of the commentaries written by Douglas, here is the evidence presented to support the allegation of scientific misconduct, along with an evaluation of the adequacy of the evidence:

1. "Senator Gillibrand worked for the New York City law firm Davis, Polk & Wardwell for eight years. From 1995 to 1999, while an associate at the firm, she played a central role in defending the world's largest cigarette company, Philip Morris, whose #1 product, Marlboro, is the most popular cigarette among children as well as adults. She represented Philip Morris when it faced several grand jury investigations and possible criminal charges from the Department of Justice."

Representing a company which is under investigation for possible civil or criminal charges is not professional misconduct. In fact, it is an unenviable yet necessary part of our system of justice. The simple fact that she represented a tobacco client does not imply that she was guilty of misconduct.

2. "When she ran for Congress, Gillibrand's campaign website reportedly did not mention her years of work on behalf of the tobacco industry. But clearly she knew, and knows, where some of the bodies were buried. She appears, using her maiden name of Rutnik, on 1,175 documents obtained from Philip Morris' company files as a result of the 1998 legal settlements between the company and state attorneys general. The caveat is that, while 775 of those documents have actually been made public, the other 400 remain confidential based on claims of attorney-client privilege."

I agree that it was inappropriate for Gillibrand's campaign website not to disclose that she had previously worked on behalf of Philip Morris. However, I do not view that as being professional misconduct as an attorney. The fact that she appears on 1,175 tobacco industry documents iw hardly evidence of professional misconduct. All it shows is that she did indeed do a lot of work for the tobacco companies. In fact, if she didn't appear on any tobacco industry documents, that might be better evidence of misconduct, because it might suggest that she was being paid without actually doing anything for the company. Finally, the fact that 775 documents have not been released due to attorney-client privilege claims is not evidence of professional misconduct. If it were, then every lawyer for every corporation that has had charges brought against it would be guilty of professional misconduct for attempting to protect documents under the attorney-client privilege claim.

3. "The documents disclose that, when she represented Philip Morris, Kirsten Gillibrand traveled to Germany at least four times to interview company scientists at a once-secret laboratory called INBIFO that Philip Morris used to conduct tobacco-and-health research that it wanted to keep away from the prying eyes of U.S. courts and American health officials. Those research projects studied nicotine addiction, cancer-causing substances in tobacco and cigarette smoke, radioactivity in tobacco, among many other things."

I simply don't see any confirmed evidence of misconduct based on the fact that Gillibrand visited the facility in Germany. What we would need to know is what advice she gave the tobacco companies. Did she instruct them to destroy documents to protect them from being found guilty of fraud? The fact of her gaining knowledge of the fact that documents were being hidden or that research was being conducted is not misconduct. Unless, of course, she advised them to continue to hide these documents on the basis of concealing fraud.

She interviewed company scientists. How is that misconduct? It would be misconduct if she instructed those scientists to conceal evidence of potential fraud. But no evidence is presented to indicate that Gillibrand advised or directed these scientists to conceal documents that she knew were evidence of fraud. For all we know, Gillibrand might have advised the scientists not to destroy documents that could have been incriminating. It seems to me that we have no idea what she advised or instructed the company or these scientists.

4. "It was at about the same time that Altria, the parent company of Philip Morris, hired Gillibrand's high-powered lobbyist father, Douglas Rutnik, in 2005-2006, to lobby for a cap on damages against tobacco companies and against a bill to restrict smoking in restaurants."

Interesting and unfortunate, but it doesn't seem appropriate to hang Gillibrand based on the actions of her father.

5. "Gillibrand must have done an exceptional job working for Philip Morris during her years at Davis, Polk & Wardwell. When she ran for Congress in 2006, her former employers contributed a cumulative $48,300 to her campaign."

If receiving tobacco industry campaign contributions is evidence of professional misconduct, then most of the Congress is guilty.

6. "I was partly responsible for the launching of the U.S. Attorney General's four-year criminal investigation of the tobacco industry, and later contributed to the successful effort to persuade the Attorney General to sue the industry under the civil racketeering laws. In both instances, I prepared detailed legal analyses and recommendations at the request of members of Congress, who then forwarded them to the Attorney General. The point of reciting my role is to highlight my familiarity with what Senator Gillibrand was involved in, and with whom she was working so hard to protect. The picture isn't pretty. (For additional background, see the book Civil Warriors: The Legal Siege on the Tobacco Industry by investigative reporter Dan Zegart, which reads like a non-fiction version of a John Grisham thriller.)"

Here, the argument is guilt by association. With whom she was working is deemed evidence of her guilt. She is being judged based on the actions of other tobacco industry lawyers. No specific evidence or analysis of Attorney Gillibrand's actions is provided.

In fact, the names "Gillibrand" and "Rutnik" do not even appear in the index of Zegart's book, which is being used to skewer Gillibrand and find her guilty of professional misconduct. Interestingly, however, one lawyer's name which does appear in the index is that of anti-tobacco lawyer Dick Scruggs, who most definitively has been found to be guilty of professional misconduct.

It's interesting to note that by Douglas' reasoning, one could accuse all anti-tobacco lawyers of being guilty of professional misconduct based on Scruggs' actions. The reasoning being used is essentially the same. One lawyer is being judged based on the actions of other lawyers representing the same clients.

Notice that Douglas is very careful to say "my familiarity with what Senator Gillibrand was involved in," rather than "my familiarity with Senator Gillibrand's actions as an attorney."In other words, Gillibrand is guilty because there are other tobacco industry attorneys who have acted in an unethical manner. Even though we don't know whether Gillibrand also acted unethically, we're going to assume that she did since she was a tobacco lawyer like these others.

This is classic guilt by association.

7. "If a professional, even a young one, has serious qualms about the type of work she or he has been asked to devote countless hours to, he or she can make a choice. Do the right thing, or become a sellout. I won't spend time tooting my own horn, but will simply say that, as an attorney and as a policy advocate, there were multiple occasions during my early career on which I declined to do work that I thought was inappropriate or inhumane. And personally I would never consider working for a law firm that defends an industry that has consciously and deliberately engaged in ongoing practices designed to lure children into a lifelong addiction that will eventually kill a large percentage of them. That choice should have been a no-brainer, Senator Gillibrand."

Esssentially, Douglas is arguing that working for the tobacco industry is inappropriate and inhumane. While I applaud him for making his own choice not to represent the tobacco companies, I do not see how representing a tobacco defendant makes one guilty of professional misconduct. Certainly, the companies have the legal right to retain counsel to defend them; thus, the simple act of agreeing to defend the companies is not professional misconduct.

1. "Let's briefly examine what is involved here by looking back at a landmark federal court decision issued on August 17, 2006 in the case of United States v. Philip Morris USA et al. In that case, brought by the U.S. Department of Justice against this nation's major cigarette companies, U.S. District Judge Gladys Kessler held Kirsten Gillibrand's client and the other defendants liable for having violated civil racketeering (RICO) laws by lying, and continuing to lie, about the health risks of smoking and secondhand smoke and their marketing to children. ... How does this relate to Senator Gillibrand's work as a lawyer defending such actions? Judge Kessler helped answer this question: 'A word must be said about the role of lawyers in this fifty-year history of deceiving smokers, potential smokers, and the American public about the hazards of smoking and secondhand smoke, and the addictiveness of nicotine. At every stage, lawyers played an absolutely central role in the creation and perpetuation of the [racketeering] Enterprise and the implementation of its fraudulent schemes. They devised and coordinated both national and international strategy; they directed scientists as to what research they should and should not undertake; they vetted scientific research papers and reports as well as public relations materials to ensure that the interests of the Enterprise would be protected; they identified "friendly" scientific witnesses, subsidized them with grants ... paid them enormous fees, and often hid the relationship between those witnesses and the industry; and they devised and carried out document destruction policies and took shelter behind baseless assertions of the attorney client privilege. What a sad and disquieting chapter in the history of an honorable and often courageous profession.'"

While it is true that many tobacco lawyers, over the course of the past five decades, have played a role in the implementation of fraudulent schemes by the tobacco industry, what specific role did Kirsten Gillibrand play in this fraud? Did she help create and perpetuate the Enterprise? Did she direct scientists as to what research they should or should not undertake. Did she carry out document destruction?

I'm not arguing that Gillibrand did not play such a role. For all I know, she might have had an industrial strength shredder and destroyed millions of incriminating documents. It's just that I admit that I don't know for sure. I have no evidence or information to go on that would allow me to make a judgment about whether Gillibrand herself acted unethically and committed professional misconduct. And therefore, I am not in a position to accuse her of such misconduct and I would never make such an accusation without having such evidence.

I thoroughly examined the entirety of Judge Kessler's decision and searched for any mention of Kirsten Gillibrand and her role in the professional misconduct of tobacco industry lawyers. There was no mention whatsoever of Gillibrand's role. In fact, the names "Gillibrand" and "Rutnik" are not found anywhere in Judge Kessler's 1700-page opinion.

So if not a mention is made in the opinion of Kirsten Gillibrand, then how can Judge Kessler's opinion possibly be used to skewer Gillibrand's character and accuse her of professional misconduct?

2. "Kirsten Gillibrand had a choice. As noted by the New York Times, "many lawyers, including some who now serve in the Senate, have defended unpopular clients. Still, in an approach that was not uncommon at law firms that represented tobacco companies, lawyers at [Gillibrand's law firm] were permitted to decline work on the tobacco cases if they had a moral or ethical objection to the work."

While it's true that Gillibrand could have declined to represent Philip Morris, the fact that she did represent the unpopular company is not attorney misconduct.

The Rest of the Story

The rest of the story is that the attack on Gillibrand and the accusation that she was guilty of professional misconduct are based on a guilty by association argumentation strategy, rather than based on specific evidence of unprofessional actions that Gillibrand individually took in her work.

I believe that if you are going to publicly skewer someone and accuse them of something so severe as professional misconduct, it needs to be based on convincing, specific evidence of their individual actions, not based on the actions of other people in the same profession.

The same reasoning that is being used to skewer Gillibrand could also be used to skewer the rest of the anti-tobacco lawyers who worked very closely with Dick Scruggs to sue the tobacco companies and obtain huge amounts of money and political prestige from the state tobacco lawsuit settlements. Scruggs was indicted twice on bribery charges and is serving a 7-year sentence in federal prision for trying to bribe two judges.

Just because Scruggs was an unethical criminal guilty of professional misconduct, does that mean that the rest of the anti-tobacco lawyers who worked on the state tobacco lawsuits also were of a similar ethical character?

Guilt by association can be a dangerous tactic and can lead to some very unfortunate consequences. That's why I find this issue very imporant. It's not simply that I find it problematic because insufficient evidence has been provided to support the accusation. It's that the very approach of guilt by association can be a dangerous one. And, furthermore, one might actually consider this guilt by association tactic to itself be questionable, if not frankly unethical.

Before closing, let me make two important points of clarification.

First, I am not in any way defending Senator Gillibrand or claiming that she is not guilty of misconduct. I'm just arguing that insufficient evidence has been presented to warrant such an accusation (and of course we assume innocence unless an individual has been proven guilty). The point is not that I have information which demonstrates that Gillibrand is innocent. The point is, instead, that there simply has not been specific evidence of her individual misconduct that has been presented to warrant such an accusation.

Second, I am not supporting Senator Gillibrand or suggesting that her acceptance of tobacco funding or work as a tobacco lawyer should not be used for political reasons, such as in campaigning against her. This is all fair game for politics. But arguing that her work for the tobacco industry makes her a bad candidate for public office is not the same thing as accusing her of professional misconduct.

Perhaps the guilt by association mentality is best demonstrated by a comment to my earlier post. In response to my noting that we don't know what Gillibrand did or did not instruct the scientists at the laboratory in Germany and therefore cannot accuse her of professional misconduct solely from the fact that she visited the lab four times, a commenter argued: "Was her legal advice beyond the pale? Did she deliberately try to hide evidence by misusing attorney-client or work-product privileges? Is this even knowable? Or are we left to draw conclusions based on what we do know about what PM's attorneys were doing for their client? As the saying goes, if you lie down with dogs, you're going to get up with fleas."

This is classic guilt by association. We don't know for sure whether Gillibrand's advice was beyond the pale or whether she deliberately tried to hide evidence by misusing attorney-client or work-product privileges and this may not even be knowable. However, we won't let that stop us from going ahead and accusing her of professional misconduct. She's working for a disreputable industry; therefore, she herself is guilty of professional misconduct.

Well, we also don't know for sure whether any of Scruggs' colleagues -- anti-tobacco lawyers who sued the industry on behalf of the states -- also engaged in bribery or other illicit or unscrupulous tactics in pursuing their cases. But because they are closely associated with Dickie Scruggs, because they lied down with a dog, have they also gotten up with fleas?

Wednesday, April 29, 2009

In a position that can only be described as absurd, the American Lung Association is seeking legislation that would give a government seal of approval to conventional cigarettes -- which are known to be extremely hazardous -- but wants demonstrably safer electronic cigarettes taken off the market because we don't know whether nicotine plus 4,000 chemicals and 43 carcinogens is worse than just nicotine.

On the one hand, the American Lung Association is a strong supporter of the FDA tobacco legislation, which even the bill's supporters admit will give a government seal of approval to conventional cigarettes and create a false impression that cigarettes have been made safer.

On the other hand, the American Lung Association is quoted in a recent WebMDarticle as arguing in favor of the removal of electronic cigarettes from the market because they haven't been studied enough to determine whether the delivery of nicotine plus thousands of chemicals and many carcinogens is more hazardous than the delivery of just nicotine. The American Lung Association's chief medical officer is quoted in that article as stating: "They are nicotine delivery devices intended to be used like a cigarette. What happens to someone who stops inhaling the tars of cigarettes and inhales only nicotine? We don't know. There is at least the potential for harm."

The Rest of the Story

What an absurd position. Electronic cigarettes deliver nicotine rather than nicotine plus thousands of chemicals but because they haven't been studied in clinical trials, they should be removed from the market. Conventional cigarettes deliver nicotine plus thousands of chemicals and many carcinogens and have been extensively studied and found to kill hundreds of thousands of Americans each year, but they must not only remain on the market but must be given an official government seal of approval.

In fact, electronic cigarettes have been studied and this laboratory testing has revealed that these products deliver just what they say they deliver: nicotine. They do not deliver other tobacco constituents in any appreciable amounts. Thus, they are demonstrably safer than conventional cigarettes. It doesn't take a clinical trial to figure this one out.

Moreover, what Dr. Edelman says about electronic cigarettes - "What happens to someone who stops inhaling the tars of cigarettes and inhales only nicotine? We don't know" - could also be said about the nicotine inhaler.

While it's true that there is the potential for harm from electronic cigarettes (nicotine may play a role in the development of cardiovascular disease), there is certainly much less of a potential for harm than there is with conventional cigarettes (which also cause lung disease and cancer).

Electronic cigarettes are being marketed to, and used by smokers, most of whom are trying to quit smoking and stay off of conventional cigarettes. Why would you want to take away this device which is helping many smokers to stay off cigarettes? Especially when conventional nicotine replacement therapy is so dismal in its efficacy.

Once again, you have to question whether the public's health is the primary concern, or whether there is a more basic ideological consideration underlying the absurdity of the American Lung Association's position on cigarettes.

Tuesday, April 28, 2009

An article published Saturday in the Los Angeles Times discusses electronic cigarettes, and the differing approaches being taken to this novel product in various countries.

While e-cigarettes are widely available in some countries, others have banned their sale. As the article reveals: "Even without smoke or fire, electronic cigarettes are sparking controversy. Australia, Canada and Hong Kong have banned them on the grounds that they have not been sufficiently tested for safety."

The article includes two important quotes from tobacco control experts. David Sweanor, an adjunct law professor at the University of Ottawa, stated: "This is exactly what the tobacco companies have been afraid of all these years, an alternative method of delivering nicotine that is actually enjoyable. It took the Chinese, who are very entrepreneurial, and not burdened with all kinds of regulation, to take the risk."

Bill Godshall, the executive director of Smokefree Pennsylvania and a frequent commenting contributor to The Rest of the Story stated: "You have these abstinence-only extremists who want to eradicate all nicotine products. But as you've seen, whether we're talking about sex or alcohol or nicotine, abstinence doesn't really work." According to the article, Godshall has "collected 4,000 signatures on a petition to allow e-cigarettes to be legally sold in the United States."

The Rest of the Story

Congratulations to Bill Godshall and to Dave Sweanor for being willing to publicly put the protection of the health of smokers above the knee-jerk, ideological opposition to a smoking device that we have unfortunately seen far too much within the tobacco control movement. Congratulations to Bill also for his efforts to persuade the FDA to allow e-cigarettes to be legally sold in the United States.

This is an important effort that could result in saving countless lives.

I find it interesting and quite informative that while anti-smoking groups are promoting nicotine replacement therapy via pharmaceutical products - which have dismal efficacy - they are seeking a ban on nicotine replacement therapy via e-cigarettes, which appear to actually be reasonably effective.

What is informative about the inconsistent treatment of these different products by the anti-smoking groups is that there does not seem to be a primary concern for the public's health. Instead, the primary concern appears to be either for the financial well-being of the pharmaceutical companies or for the ideological notion that the act of using a cigarette-like device is to be scorned.

It is absurd to argue that e-cigarettes must be banned because they have not been sufficiently tested for safety. Regular cigarettes have been sufficiently tested for safety and they have been found to be unsafe. But they are still on the market. So why all the concern about testing e-cigarettes for safety? Since they deliver nicotine but not the tar, we know that they are going to be safer than conventional cigarettes. I maintain that it isn't truly safety and health concerns that are leading the anti-smoking groups to call on an e-cigarette ban. I think it is a combination of the financial influence of the pharmaceutical companies on tobacco control and the ideological resistance to the idea that any act of smoking could be tolerated.

Monday, April 27, 2009

The anti-smoking organization SmokeFree Wisconsin has accused tobacco companies of using electronic cigarettes as a ploy to hook youths on these products. The group asserts that these products are being marketed to kids by virtue of their being produced in fruit flavors. For these reasons, SmokeFree Wisconsin joins a number of other health groups in supporting efforts to remove electronic cigarettes from the market.

SmokeFree Wisconsin writes Saturday in its blog entry entitled "E-cigarettes: The Latest Ploy By Big Tobacco to Hook Kids": "A recent call to our office prompted us to look further into the emerging issue of 'e-cigarettes.' A group of public health advocates has urged the Food and Drug Administration (FDA) to pull e-cigarettes (or electronic cigarettes) from sale in the United States. ... E-cigarettes are often made to look like conventional tobacco products and are marketed to kids by producing them in fruit flavors. A united group of public health advocates, including the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and the Campaign for Tobacco-Free Kids, sent out a press release commending Senator Frank Lautenberg of New Jersey for demanding that the FDA remove e-cigarettes from the marketplace. FDA officials have been quoted in the past few weeks saying e-cigarettes are a 'new drug' that needs to be approved by the government before it can be sold."

The Rest of the Story

Unfortunately, SmokeFree Wisconsin is spreading misinformation.

While it might make an appealing story, it is not true that electronic cigarettes are a ploy by Big Tobacco to hook kids. Electronic cigarettes are actually not produced by the major tobacco companies. They are not produced by tobacco companies at all. There are a number of companies selling these products, but to the best of my knowledge, none of them is affiliated with Big Tobacco.

Thus, it is demonstrably false that e-cigarettes are a ploy by Big Tobacco to hook kids.

The truth is that electronic cigarettes are being marketed not to try to recruit youths to smoking, but to fill an important niche in the market: the need for a more effective smoking cessation product.

Traditional smoking cessation aids -- including nicotine replacement therapy -- have a dismal track record, with long-term success rates in the single digits. Thus, there is a need for a product that will be much more effective in helping smokers to get off cigarettes. Perhaps because they model smoking behavior - delivering nicotine but without the tobacco - electronic cigarettes appear to be a much safer alternative to smoking and they also appear to be reasonably effective in helping smokers to stay off cigarettes.

Although it is true that electronic cigarettes can be used with various flavorings, it is not the case that these flavorings are being marketed to appeal to youths. Quite clearly, the intention of the electronic cigarette manufacturers is to take advantage of the huge potential market of smokers who want to quit smoking but have very little faith in (or have had an unsuccessful experience with) traditional nicotine replacement products.

Taking electronic cigarettes off the market would be a huge mistake from a public health perspective. It would almost certainly result in a return to cigarette smoking by most e-cigarette users. This would result in increased disease risk, as these individuals would be exposed to nicotine and all the carcinogens and toxins in tar, rather than just nicotine.

While it is of course reasonable to institute measures to ensure that youths do not get their hands on e-cigarettes, taking the product off the market would be detrimental to the public's health.

SmokeFree Wisconsin should correct its misinformation so that it doesn't continue to mislead the public. And if it is truly concerned about the public's health, rather than just about whether people are taking part in the act of smoking a cigarette-like product, SmokeFree Wisconsin should renounce the other public health groups' call for a ban on the sale of electronic cigarettes.

Friday, April 24, 2009

In response to the appointment of former New York state representative Kirsten Gillibrand as the Senator to replace Hillary Clinton, a number of anti-smoking advocates have attacked Gillibrand because she previously represented tobacco companies as an associate attorney in the law firm Davis, Polk, & Wardwell. Because she represented tobacco company defendants in court cases, anti-smoking advocates have called Gillibrand a "sellout."

For example, in calling Gillibrand a "sellout" for agreeing to represent Philip Morris in the courtroom, Cliff Douglas - the executive director of the University of Michigan Tobacco Research Network - bases his personal attack on the following: "Senator Gillibrand worked for the New York City law firm Davis, Polk & Wardwell for eight years. From 1995 to 1999, while an associate at the firm, she played a central role in defending the world's largest cigarette company, Philip Morris, whose #1 product, Marlboro, is the most popular cigarette among children as well as adults. She represented Philip Morris when it faced several grand jury investigations and possible criminal charges from the Department of Justice."

Douglas impugns her integrity and character, arguing that defending the tobacco companies is "inappropriate" and "inhumane" and that if Gillibrand had any integrity she would have declined to represent a tobacco industry client. He writes: "I won't spend time tooting my own horn, but will simply say that, as an attorney and as a policy advocate, there were multiple occasions during my early career on which I declined to do work that I thought was inappropriate or inhumane. And personally I would never consider working for a law firm that defends an industry that has consciously and deliberately engaged in ongoing practices designed to lure children into a lifelong addiction that will eventually kill a large percentage of them. That choice should have been a no-brainer, Senator Gillibrand."

Writing on the Huffington Post, Christopher Brauchli went so far as to opine: "The Senator is not qualified to hold public office."

Despite having represented Philip Morris in the courtroom and having received tobacco industry campaign contributions, Gillibrand actually has voted consistently for tobacco control policies. A staunch anti-smoking advocate, Matt Myers, president of the Campaign for Tobacco-Free Kids, stated: "As a member of Congress, Senator Gillibrand has a record of supporting strong measures to reduce tobacco use. Senator Gillibrand several times voted for legislation, now law, to significantly increase federal tobacco taxes to fund expansion of the State Childen's Health Insurance Program. As a member of the House, she also co-sponsored and voted for legislation to grant the FDA authority over the manufacturing, marketing and sale of tobacco products."Senator Gillibrand apparently has a 100% anti-smoking voting record, having supported the SCHIP cigarette tax increase, the FDA tobacco legislation (although arguably that vote could be called "pro-tobacco" but I won't get into that here), and 100% smoke-free bar and restaurant laws.

The Rest of the Story

These personal attacks on the integrity and character of Senator Gillibrand, based on the fact that she represented Philip Morris in court, are unwarranted and unjustified. Moreover, the opinions of anti-smoking advocates that Senator Gillibrand is a sellout and that she is unqualified for office because she defended a tobacco company in court are unfortunate.

In order to have a democracy and a system of justice, it is absolutely imperative that all defendants - even the most eggregious criminals - be entitled to legal defense. The tobacco companies are perfectly entitled to legal representation and to the full protection of their legal rights under the law.

Someone has to represent the tobacco companies and there is no shame or defect in integrity or character associated with agreeing to be that person.

The opinions being expressed by Douglas and other anti-smoking advocates are dangerous to the system of justice in this country, because they undermine the basic principle that, as Dorothy Samuels expresses it: "The American adversarial system of justice depends on the willingness of lawyers to vigorously represent unpopular, even odious clients."

For this reason, I believe it is inappropriate, unwarranted, and actually dangerous for anti-smoking advocates to be criticizing Senator Gillibrand for representing Philip Morris, regardless of the inappropriate or even illegal behavior that may have been committed by this tobacco company. They are entitled to a vigorous defense and those who provide that defense are protecting - not undermining - the integrity of the American system of justice that separates the United States from many other countries.

Regardless of her work for Philip Morris in the past, there is no evidence that has been presented that Gillibrand has cast a single vote that was influenced or biased on the basis of her previous representation of Philip Morris. Even the Campaign for Tobacco-Free Kids admits that she has been a strong tobacco control supporter (albeit I disagree with their view of whether a vote for the FDA legislation represents a pro- or anti-tobacco position).

The kinds of opinions being expressed by Douglas and others in tobacco control actually undermine the ability of the justice system to provide an appropriate defense for tobacco companies and other "unseemly" clients. The scorn and personal attacks that are being issued publicly against Gillibrand will discourage attorneys from taking on such clients, thus limiting the pool of available representation and precluding the ability of such clients to obtain the best possible defense.

Moreover, these attacks frame the issue inappropriately in the public eye, and undermine the public's appreciation for an essential aspect of the very integrity of our justice system.

While Gillibrand's acceptance of tobacco industry campaign funds is fair game for criticism, her decision to represent Philip Morris as a legal client is not. While anti-smoking advocates apparently would like to see a legal defense denied to these companies, such an outcome would be a travesty of justice that would make the United States no better than other countries which deny their citizens the right to a fair trial.

Thursday, April 23, 2009

A study that is scheduled to be presented this week at the annual meeting of the American Physiological Society concludes that very brief exposure to tobacco smoke, wood smoke, and cooking oil fumes all cause potentially damaging cardiovascular changes (see press release; see news article). The study was conducted by researchers at the University of Kentucky and the Oak Ridge National Laboratory and was funded by Philip Morris (Evans JM, Patwardhan AR, Jenkins RA, Ilgner RH, Hartman EC, Jayanthi AK, Knapp CF. Autonomic responses of men and women to particulate exposures. Presented at the 122nd Annual Meeting of the American Physiological Association, New Orleans, LA, April 18-22, 2009).

The study was conducted in experimental environmental chambers at the Oak Ridge National Laboratory. Healthy nonsmoking volunteers were subjected to a 10-minute exposure to either tobacco smoke, cooking oil, wood smoke, or water vapor (the control). Cardiovascular parameters were measured before, during, and after exposure.

The study found that there was "increased sympathetic dominance in control of heart rate during exposure to all particulate exposures" and that "vasomotion increased in response to all particulate exposures."

The press release summarizes the main study findings as follows: "The study found that, particularly among men, exposure to smoke changed breathing patterns, raised blood pressure oscillations in peripheral arteries and shifted control of heart rate toward sympathetic domination. The sympathetic nervous system becomes active during times of stress, but can cause harm to the heart and blood vessels if activated too often or too long."

The news article summarizes the main result as follows: "The study confirmed previous research that has shown that smoke harms cardiovascular function and extended those findings by showing that this harm can occur with lower levels of smoke and shorter exposure times."

The Rest of the Story

This study is important, in part because it demonstrates that a variety of short-term exposures to particulate matter -- including not only tobacco smoke but also wood smoke and cooking oil fumes -- cause cardiovascular effects that could potentially be damaging, and might plausibly be a trigger for an acute cardiovascular event among individuals with severe, pre-existing heart disease.

But importantly, the study demonstrates that secondhand smoke is not unique in triggering such cardiovascular changes after acute exposure. All of the particulate exposures studied had the same effect.

What does this mean in practice? What it means is that the conclusion of many anti-smoking researchers and groups -- that smoking bans will immediately reduce heart attacks because nonsmokers will no longer have heart attacks triggered by brief secondhand smoke exposure -- is not a sound one. If any short-term (even 10 minute) exposure to any type of smoke or even to cooking fumes can cause acute cardiovascular changes that may trigger a coronary event in a susceptible individual, then simply removing one of those exposures may not necessarily decrease the incidence of heart attacks.

The point is this: if someone's cardiovascular health is so "fragile" that a brief exposure to tobacco smoke may precipitate an acute coronary event, then that person may also be "triggered" by almost any other exposure to particulates, as well as to a range of other exposures which may cause adverse cardiovascular effects, including eating a high-fat meal or experiencing stress.

Thus, it is unlikely that these heart attacks could be prevented simply by banning smoking in bars and restaurants. These individuals are almost certainly going to experience other exposures that affect their cardiovascular system in the same way that secondhand smoke would have.

Thus, even if it is the case that brief secondhand smoke exposures are triggering thousands of heart attacks each year (a fact that has not yet been proven), it is not necessarily true that smoking bans will prevent these heart attacks from occurring.

The bottom line is that anti-smoking and health groups (including the CDC itself) have gone beyond solid science in suggesting that smoking bans are resulting in immediate reductions in heart attacks because of the elimination of a major trigger for these heart attacks. The heart attacks will likely occur anyway, and at the same rate, because it is impossible for individuals to avoid exposure to every possible factor that will also induce the same types of changes in cardiovascular function as observed with short-term tobacco smoke exposure.

The study is also important, of course, because it demonstrates a biologically plausible mechanism by which long-term exposure to particulate matter in smoke can cause cardiovascular disease. While short-term activation of the sympathetic autonomic nervous system is not necessarily harmful if it occurs only occasionally, chronic activation of this system could be harmful to the heart and blood vessels and could result in heart disease.

Many of my colleagues will probably respond to this commentary by pointing out that the study was funded by Philip Morris and that the Oak Ridge National Laboratory has a long history of tobacco industry funding. Nevertheless, one must still look at the actual scientific merit of the work that was conducted. The study is methodologically sound and the conclusions are very well supported by the findings that are presented. There is no reason to dismiss the study simply because of its funding source.

If anything, the researchers have provided quotes to the media that are highly unfavorable to the tobacco companies (arguing that even low levels of exposure to secondhand smoke may be hazardous, and even more dangerous than previously thought). This demonstrates that one must not rely on an ad hominem approach in critiquing the scientific literature.

Wednesday, April 22, 2009

Two state legislative committees in Florida yesterday approved measures that would cap the amount of the appeal bonds that tobacco companies must pay if there are judgments against them in the more than 8,000 lawsuits by sick smokers who have sued the companies for damages.

Normally, when a company loses a lawsuit in Florida and there are damages awarded, it must pay an appeals bond equal to the amount of the judgment in order to guarantee that it will pay the damages if they are upheld upon appeal. With more than 8,000 outstanding lawsuits against the tobacco companies, state lawmakers have become worried that the payment of these bonds might jeopardize the payments that the tobacco companies make to the state of Florida under the state's tobacco settlement -- money which goes towards a variety of critical government programs and services. Thus, in order to protect the state's financial interests, lawmakers have proposed giving the tobacco companies special protection by capping the total amount of the appeals bonds they would be required to pay.

According to an article in the St. Petersburg Times: "More than 8,000 sick smokers in Florida have sued the tobacco industry for misleading claims but on Tuesday two legislative committees pushed through bills that will cap how much the industry is required to set aside in the event it loses those cases. The House Finance and Tax Council and the Senate Judiciary Committee passed similar bills that would shield Philip Morris, R.J. Reynolds Tobacco and Lorillard from having to post hefty bonds as they face an avalanche of lawsuits from smokers. The measures would allow the three companies to set aside a total of no more than $100 million in bond money in order to appeal the verdicts. Under state law, when a company loses a lawsuit and wants to appeal, it must post a bond for the entire amount of the judgement."

"Trial lawyers complained the measures will remove the financial incentive for the tobacco giants to pay their judgements or settle their cases. Instead, they said, it will encourage the companies to pursue endless appeals and delays designed to financially break plaintiffs or wait until they die."

"Promoters of the bills — House Finance and Tax Council chairwoman Ellyn Bogdanoff and Melbourne Republican Sen. Mike Haridopolos — said the measure is needed to give the industry financial certainty, and to protect the state's annual $205 million payment by the tobacco companies as part of the landmark 1997 settlement with the industry." ...

"Robert Hanrech, a Miami lawyer representing some tobacco plaintiffs, said that in a Feb. 26 Goldman Sachs statement to shareholders, one tobacco company said the 8,000 claimants stemming from the class action lawsuit "fails to pose a significant threat. 'This would be a bailout for tobacco,' he said. 'They would be getting an unfair advantage when they don't need it.'"

The Rest of the Story

This story reveals that the Master Settlement Agreement, individual state settlements with tobacco companies, and cigarette tax increases that use tax revenues to fund essential government programs have a disastrous side effect on the public's health: they create a financial partnership between the states and tobacco companies which leads state lawmakers to go to great extremes to protect the financial interests of Big Tobacco, even when that protection represents a government bailout and is completely unnecessary.

The Florida legislature has become the greatest friend that Big Tobacco could ever ask for. As a result, it turns out that the settlement of the state's lawsuit against the tobacco industry had the worst possible consequences for the public's health. Not only has the state failed to use the settlement revenues to fund anti-smoking programs, as was originally intended, but state lawmakers have now become the industry's greatest financial allies, going to unprecedented extremes to protect tobacco company profits.

Large increases in cigarette taxes create the same problem when the revenues are allocated towards essential government programs, rather than towards programs that are directly related to smoking and smoking-related diseases. The government becomes dependent upon high levels of cigarette consumption for the solvency of its essential programs, and lawmakers thus become financial advocates for Big Tobacco, with a vested interest in working to protect the companies from any policies that would substantially reduce cigarette consumption.

The tragedy of the Florida lawmakers' actions is that individual citizens are being denied their legal rights to hold the tobacco companies accountable for their actions. Their legal rights are being sacrificed to bail out the cigarette companies and to protect the financial interests of the state of Florida. The measure ensures that very few of the sick smokers in Florida will receive damages, even if juries award them. It also ensures that lawyers will be reluctant to file any tobacco litigation in the future.

Essentially, Florida lawmakers have rewarded the tobacco companies with virtual immunity from litigation. The price for that reward: nothing other than having the brilliance to take advantage of the money-seeking greed of state politicians.

This should be a warning signal to tobacco control groups to re-think their support for large cigarette tax increases where the revenue is used to fund non-tobacco-related programs. These policies create a financial dependence of the state budget on continued high levels of cigarette consumption and make the states financial partners of Big Tobacco.

In a press release issued yesterday, the Citizens' Commission to Protect the Truth -- "a group composed of every former U.S. Secretary of Health, Education and Welfare and Health and Human Services, with the exception of Michael Leavitt; every former U.S. Surgeon General; and every former Director of the Centers for Disease Control and Prevention" -- is promoting increased funding of the American Legacy Foundation's "truth" anti-smoking campaign and calling on the tobacco companies to voluntarily agree to provide funding for the "truth" campaign.

According to the press release: "The truth(R) youth anti-smoking campaign has the power to save hundreds of thousands of lives and billions of dollars in smoking-related health care costs and productivity losses ... We believe that if the truth(R) campaign continues for another five years (2009-2015) with similar effectiveness, there will be up to 500,000 fewer youth smokers with savings of up to $9.0 billion in future medical costs. ... Among its efforts, the Commission is demanding that big tobacco companies continue financing the Public Education Fund under the Master Settlement Agreement reached with the states in 1998. After March 2003, the tobacco companies (Phillip Morris (Altria), Brown and Williamson, R.J. Reynolds and Lorillard) were no longer required under the agreement to make annual payments to the Public Education Fund, which enables the American Legacy Foundation to conduct the truth(R) campaign. The payments are required only if the participating tobacco manufacturers control 99.05 percent of the cigarette market. Although participating companies no longer meet that threshold, their market share remains well above 90 percent."

The Rest of the Story

What the Citizens' Commission to Protect the "Truth" does not reveal in its press release is that it was funded by a grant from the American Legacy Foundation. According to the Citizens' Commission web site: "Principal funding for The Commission comes from the National Association of Attorneys General through a $1.5 million pass-through grant from the American Legacy Foundation."

Thus, the Citizens' Commission is little other than a front group created to have the appearance of an independent commission of "citizens" who are objectively struck by the success of the "truth" campaign and who therefore want to promote its funding, but which in reality was funded by the American Legacy Foundation to advocate for increased Legacy funding. In other words, what Legacy essentially did was fund a front group to advocate for itself. It is a front group because it fails to readily reveal its funding from Legacy. The public is kept in the dark about this financial relationship and is severely misled into thinking that the Citizens' Commission is some sort of private group that is completely independent of the American Legacy Foundation.

What this represents is deception and trickery of the lowest order. It is, in fact, a tactic that the tobacco companies used to employ all the time, and those of us in tobacco control blasted the companies for its use of front groups.

Now, however, it is the tobacco control movement that is using a front group, trying to elicit more funding for itself.

To make matters worse, the Citizens' Commission is seeking voluntary agreement by the tobacco companies to fund the "truth" campaign (even though the companies' obligations to fund the Public Education Fund under the Master Settlement Agreement ended in 2003). The hypocrisy of such an action is astounding, since it was the American Legacy Foundation which refused to grant funds to any public health school that took tobacco money.

Apparently, when a university takes tobacco money it is evil and unacceptable, but when Legacy itself takes tobacco money it is suddenly acceptable. What hypocrisy. Tobacco money is tainted if you are a university desperate to obtain funding for research, but the money suddenly becomes clean if you are the American Legacy Foundation and in desperate need of money to fund your own program.

Moreover, asking the tobacco companies to fund the "truth" campaign would emasculate it. The campaign could no longer employ hard-hitting advertisements that attack the tobacco companies because any such ads would result in the companies changing their minds and discontinuing their funding of the program. The tobacco companies would essentially be running the show. That's really the last thing in the world that we should want.

The rest of the story is that the Citizens' Commission is basically a front group for the American Legacy Foundation. It apparently receives funding primarily from the American Legacy Foundation to conduct its primary business which is to advocate for funding for the American Legacy Foundation. But without readily disclosing (such as in its press releases) its financial affiliation with Legacy.

I find this to be dishonest. It is hiding the truth, which is rather ironic considering that the so-called purpose of the group is to protect the truth and the campaign which the group aims to obtain funding for is the "truth" campaign. Nothing like using a little deception to try to get funding for a campaign to tell the truth.

Unfortunately, the Citizens' Commission has a long history of hiding its financial affiliation with Legacy and thus acting the way a traditional tobacco industry front group acts (hiding its financial ties to Big Tobacco so that the group doesn't lose legitimacy that it would give up if it were clear that the group advocating for Big Tobacco interests was not in fact independent from the cigarette companies).

In fact, the original press release announcing the formation of the Citizens' Commission declared that the former HHS secretaries, Surgeon Generals, and CDC directors were forming a citizens' commission to try to increase funding for the American Legacy Foundation's "truth" campaign, but did not disclose the fact that the Commission was in fact a financial outgrowth from the American Legacy Foundation.

It certainly wouldn't have sounded as impressive to state: "The American Legacy Foundation has decided to fund a group to try to obtain increased funding for the American Legacy Foundation." That just doesn't have the same sting to it. The truth can have a funny way of sometimes getting in the way.

But while it's wrong for the tobacco companies to let the truth get in the way, it's apparently not a problem as long as your goal is to stop tobacco use, rather than promote it.

I find it unfortunate that the American Legacy Foundation and the Citizens' Commission have set such low ethical standards for the rest of the tobacco control movement to follow. Sinking as low as essentially setting up a front group - which was a common tobacco industry tactic - is not exactly the kind of leadership we need right now in tobacco control.

Ironically, those who are trying to protect the "truth" need to start being a little more forthcoming with the truth.

If the leading organizations in tobacco control do not tell the truth, how can we expect to have any credibility in demanding that the tobacco companies end their own deceptive practices? It's like the pot calling the kettle black.

Monday, April 20, 2009

According to the SceneSmoking.org web site, run by Breathe California of Sacramento-Emigrant Trails, 340 young people a day continue to die from smoking. As the web site puts it: "Smoking Kills About 340 Young People a Day."

While smoking is obviously a terrible public health problem and it is estimated to cause over 400,000 deaths per year, it is simply not true that 124,000, or 31% of those deaths, occur among "young people." It is rare for smoking to kill people below the age of 40. Most of the deaths from smoking are caused by heart disease, lung cancer or other cancers, and chronic lung disease -- all of these are conditions that generally do not set in until at least middle-age. Only rarely does one see a young adult die from smoking.

This is not to minimize the health effects of smoking; it is merely to point out that the statistic being communicated by this anti-smoking group is factually inaccurate.

The casual observer might understandably surmise that this communication on Breathe California of Sacramento-Emigrant Trails' web site is simply an honest or careless mistake.

The Rest of the Story

The rest of the story is that Breathe California of Sacramento-Emigrant Trails has been aware of this inaccurate statistic on its web site since at least October 22, 2007, when I first notified the group of the error. If this were just an innocent mistake, I think it would be reasonable to assume that the organization would quickly change the web page to correct the mistake.

However, as you can see, the "mistake" persists to this day.

In fact, several months after I first wrote to the group, asking why they hadn't yet changed the web page, I was told that the reason for the failure to correct this statistic was that the web master was unavailable (presumably on vacation).

All I can say now is that it's been one heck of a long vacation: from October 22, 2007 to April 20, 2009. That's 18 months - one and a half years!

I would love to have that web master's job.

To state that 340 young people die each day because of exposure to smoking in movies is ludicrous. And patently false.

I really don't understand this need to lie to the public, or to stretch the truth beyond recognition, in order to make a point to the public. Forgetting about my argument that there is no valid scientific support for the claim that smoking in movies leads more than 200,000 kids to start smoking each year, if SceneSmoking.org wanted to accept this statistic from one author, then what would the problem have been in stating that 340 young people will eventually die prematurely due to smoking in movies?

The problem, as far as I can see, is that it would not have been sensational enough. Apparently, it is no longer enough to tell the truth in tobacco control. It is not good enough to accurately represent the science.

You need to lie in order to sensationalize your message. You need to misrepresent the facts. Otherwise I guess you're not doing your job.

Based on the fact that the organization has known about this inaccurate statistic for the past 18 months yet failed to correct it, it seems implausible to me that Breathe California of Sacramento-Emigrant Trails has any sincere interest in making sure that it communicates truthfully and accurately to the public. If it did, then why would it not have corrected the problem 18 months ago, 17 months ago, or even 16 months ago?

When I find a mistake on my web site, I correct it immediately. I don't wait 18 months. And while it's true that I don't have a web master who I need to contact to make the correction, I find it hard to believe that any web master is completely out of the reach of modern-day communication for 18 consecutive months.

Instead, it seems to me that perhaps the organization just doesn't care about the scientific accuracy of its public claims. After all, the end goal is viewed as a noble one, so what does it matter if you stretch the truth a little?

Unfortunately, I don't support the end policy that this group is working towards, because if the problem is really as great as it is and 248,000 kids each year start smoking because of seeing smoking in movies, then how can Breathe California of Sacramento-Emigrant Trails possibly support a policy that allows the depiction of smoking in movies if it is historically accurate? If smoking is causing that many kids to eventually die, then what does it matter if the smoking is historically correct or not?

By making an exemption for historically accurate depiction of smoking in the recommended policy of an R-rating for all films that depict any smoking at all, what these anti-smoking groups are actually doing is regulating the artistic expression of film makers, not a health concern. If it were a true concern for health, then it wouldn't matter whether a character smoked in real life or not? The problem would be defined as exposure to smoking in movies, not exposure to historically incorrect or unnecessary smoking in movies. By attempting to regulate only smoking that is deemed "unnecessary," anti-smoking groups are actually regulating artistic expression, not protecting the public's health.

I challenge Breathe California of Sacramento-Emigrant Trails to either provide the data showing that 124,000 "young people" die each year from smoking or to remove this statistic from its web site.

In the mean time, I'm going to try to find myself a job as a web master for an anti-smoking group, so that I too can enjoy an 18-month vacation. We can call if a sabbatical with time and a half.

Friday, April 17, 2009

A new book soon to be released by the Democracy Institute provides the most comprehensive analysis and critique of the issue of FDA regulation of tobacco products ever produced. Patrick Basham, director of the Democracy Institute, analyzes the history of the FDA tobacco legislation, the nature of the negotiations that led to the crafting of the bill currently before Congress, the interest of Philip Morris in pursuing regulation, the likely effects of the bill, the basic policy issues involved in regulation of tobacco products, and the merits of the overall regulatory scheme created by the proposed legislation.

Basham has taught tobacco regulation and policy courses at the Johns Hopkins University and his thinking was influenced by vigorous debates in his classes, in which various sides of the issue were considered. Thus, his opinions are informed by knowledge of the interests of both the public health advocates and the tobacco executives who negotiated the bill. The book is a must-read for anyone who is interested in the tobacco issue, and I believe it should be required reading for every organization that is supporting the legislation.

From his extensive and detailed analysis of the scientific, regulatory, and policy issues, Basham concludes that "giving the FDA the authority and the responsibility for a good chunk of the U.S. tobacco file is a mistake of epic proportions."

He writes: "Handing tobacco regulation over to the FDA is tantamount to giving the keys of the regulatory store to the nation's largest cigarette manufacturer, Philip Morris. that is because the legislation on FDA tobacco regulation has been cooked up out of public sight over the last few years by a partnership of Philip Morris, certain groups from the public health establishment, and Senator Edward Kennedy and Congressman Henry Waxman."

"Kennedy, Waxman, and the public health establishment, led by the Coalition for Tobacco-Free Kids, are presenting their proposed legislation as a masterful regulatory stroke that will end tobacco marketing, prevent kids from starting to smoke, make cigarettes less enjoyable to smoke, and reduce adult smoking. But FDA regulation of tobacco will do none of these things. That is because Philip Morris skillfully hoodwinked a coalition of 'useful idiots,' including the Campaign for Tobacco-Free Kids, Senator Kennedy, and Congressman Waxman, at every turn. ... FDA regulation of tobacco will serve the interests of Philip Morris, not the interests of the anti-tobacco movement nor their sage congressional partners, and most assuredly, not the interests of the American public."

Basham defines "useful idiots" as "those members of the anti-tobacco movement whose naivete was exploited by, and to the benefit of, Philip Morris."

How we got to such a situation, how the Campaign for Tobacco-Free Kids and other anti-smoking groups were hoodwinked into negotiating with Philip Morris and supporting the resulting legislation, is the fascinating subject of the first two chapters of "Butt Out!" Basham describes how FDA regulation of tobacco products was actually part of a plan by Philip Morris to capture regulation: giving it the public appearance of being a reformed company that is willing to subject itself to strict safety standards but through carefully crafted compromises, ensuring that the true effect of the legislation would be to further the company's financial interests.

Basham reveals that the legislation was the result of a secret, carefully hidden negotiation between Philip Morris and the Campaign for Tobacco-Free Kids. These tough negotiations resulted in number of important compromises by the public health groups that severely limited FDA's regulatory authority. Worse, the Campaign for Tobacco-Free Kids never told the truth about the fact that it was negotiating with Philip Morris, a fact that it has still not disclosed.

Importantly, Basham does not dismiss the legislation simply because it was negotiated with Philip Morris. That fact leads to his giving critical scrutiny to the details of the legislation. But his condemnation of the legislation is based on a detailed analysis of the actual provisions of the bill, which is provided in Chapter 3. Basham goes through a checklist of the potential public health benefits of the legislation, and based on a review of the scientific evidence, concludes that very few of the bill's provisions will actually serve public health interests. He argues that the public health groups have indeed been outsmarted and that the bill serves the interests of Philip Morris, not those of the anti-tobacco movement.

Chapter 4 provides a detailed analysis of several of the central provisions of the legislation. The one measure which might legitimately be thought to have positive health benefits - the mandated warning labels - will likely not be effective, Basham argues, based on research into psychological reactance theory. The regulation of nicotine levels may actually be counterproductive, because lowering nicotine levels will result in greater tar exposure. Basham also offers some thoughts as to how and why the anti-tobacco groups got it so wrong.

In Chapter 5, Basham provides a more basic argument against FDA regulation of tobacco products: that the bill would burden an already troubled agency and undermine its basic mission.

Finally, in chapter 6, Basham shares his own thoughts about what a sensible, science-based, and effective national strategy for tobacco control might look like. I'll leave readers to order the book to see the approaches that Basham suggests, but one point he emphasizes is that whatever the approach, unlike the current FDA legislation, it must be transparent, guided by accurate science rather than by ideology, blind faith, or politics, and it must communicate accurate scientific information to the public.

This book is a must-read for Rest of the Story readers and anyone interested at all in tobacco control policy.

The Rest of the Story

In light of the revelations brought forward in "Butt Out," I challenge the Campaign for Tobacco-Free Kids and other anti-smoking and health groups which are supporting the FDA tobacco legislation to:

1. Publicly acknowledge that the legislation was the result of a Congressionally-mediated negotiation between the Campaign for Tobacco-Free Kids and Philip Morris.

2. Publicly acknowledge that the Campaign for Tobacco-Free Kids and other groups have been deceiving the public and their own constituents by hiding the fact that the legislation was crafted, in part, by Philip Morris, which played a major role at the negotiating table.

3. Publicly acknowledge that the many loopholes in the bill that severely limit the FDA's authority represent compromises that were made to appease the financial interests of Philip Morris, and that they do compromise public health protection in order to retain Philip Morris' support for the bill.

4. In light of the revelations and detailed analysis in "Butt Out," to renounce their support of this legislation and instead, join me in helping to craft a truly effective science-based piece of federal legislation in an open, transparent, and inclusive process -- guided by science and evidence, rather than ideology, blind faith, and politics -- that will actually result in a significant reduction in adult and youth smoking, and therefore, in substantial public health protection.

Thursday, April 16, 2009

An article published in the current issue of Administrative Law Review, published by the American University Washington College of Law, analyzes the FDA tobacco legislation currently before the United States Senate and concludes that enactment of this bill would be a public health disaster, resulting in the FDA becoming complicit with the tobacco companies in harming the public's health (see: Barker KG. Thank you for regulating: why Philip Morris's embrace of FDA regulation helps the company but harms the agency. Administrative Law Review 2009; 61(1):197-224).

The article provides a thorough analysis of the history of legislation that would give the FDA authority to regulate cigarettes as well as of the details of the legislation currently before Congress. The major conclusions of the analysis are as follows:

1. While the bill, on the surface, appears to be a comprehensive piece of tobacco regulatory legislation, "Upon closer look, however, the legislation contains crucial industry-lobbied compromises that would give Philip Morris the benefits of regulation, while allowing the company to mitigate disadvantages."

2. While [the bill's] public-health benefits are unclear, what is more disturbing is that the bill's provisions might wreck an already-embattled FDA. [The bill] would logistically burden the agency and potentially render FDA an unwilling participant in Philip Morris's public-relations move."

3. The bill is "the latest example of big business capturing regulation." By this, Barker means an industry fending off stronger (and perceived inevitable) regulation by agreeing to weakened legislation that appeases public health advocates and lawmakers but mitigates any serious harms to the industry.

4. The bill represents "compromise-laden legislation [that] would structurally burden FDA and undermine its mission of protecting the public health."

5. The paper's ultimate conclusion is that: "forcing FDA to issue standards for approving what would still be deadly products creates an ideological crisis. Cigarette companies' survival depends on maintaining smoking rates. The public health depends on reducing smoking rates. Since reduced-risk-branded cigarettes would inform the public that the product had been made safer, it is likely that more people would smoke. If more people smoke because of an FDA rule, then the agency would be complicit with the tobacco companies in harming the public health."

The review explains how the bill follows the historical model of industries "capturing" regulation through its numerous loopholes, by which the FDA is rendered essentially powerless and the tobacco companies - especially Philip Morris - are given the power to effectively fight and resist any meaningful regulation. Barker explains that the compromises in the bill allow the industry to fight any regulation that would harm its profits and predicts that the industry will overwhelm the FDA with "drawn-out appeals processes" that will "discourage future industry-harming regulatory measures and could be almost as effective as winning on appeal."

Thus, Barker sees the bill's tobacco product standards as a pointless exercise in futility that will not result in any meaningful protection of the public's health.

In addition, Barker argues that the bill's "reduced exposure" provisions will create a false impression that cigarettes have been made safer, giving tobacco companies a tremendous marketing opportunity at the expense of the deception of their consumers. As Barker states: "reduced-exposure branding would only foster consumers' unscientific, unfounded inferences."

Furthermore, Barker points out that the FDA is already "riddled with problems" and that this legislation would overwhelm the agency and possibly lead to an institutional disaster from which it would "take decades to recover." Also, Barker argues that the legislation would undermine the agency's mission of protecting the public's health. Worst of all, it would actually make the FDA complicit in harming the public's health, as FDA regulation will create the perception that cigarettes are safer -- leading to increased smoking -- when they are actually not.

Thus, the bill will not only increase smoking rates but it will lead to essentially the defrauding of the American public. The only difference between the bill's regulatory scheme and the status quo is that the defrauding will be carried out by the federal government, rather than by the tobacco companies themselves.

Ultimately, Barker argues against the passage of the FDA legislation and suggests that FDA regulation of tobacco products is not a sensible idea in the first place. But he warns that if such an approach is considered, the approach taken by the Campaign for Tobacco-Free Kids with this bill is not an appropriate way to develop public health policy: "if FDA regulation is the means chosen to combat cigarette smoking and tobacco-related health problems, Congress must give broad regulatory authority to the agency. The bill cannot have compromises with the industry and certainly cannot contain a tobacco product standard that invites courtroom challenges, nor can it have a deadline that requires FDA to issue rules that might ultimately harm the public health. While reporters, industry competitors, and public-health advocates have tried to understand for years why Philip Morris supports FDA regulation, the answer is somewhat obvious: when legislation provides for tamed regulation, the agency is already captured."

The Rest of the Story

This analysis of the FDA tobacco legislation is an important one, because it comes from a neutral source: a law student who is not otherwise involved in the tobacco issue. His stinging indictment of the legislation and of the process by which the bill came to be should be a striking wake-up call to the health groups which are supporting this legislation.

Barker makes many of the same arguments I have advanced on this blog, but comes to his conclusions based on an objective and independent analysis of the legislation.

The health groups supporting this bill owe it to the public to respond to the criticisms leveled by Barker in this article. After all, the charges he makes are serious ones: if correct, this legislation will:

1) transfer the fraud that was committed by cigarette companies over into the hands of the federal government;

2) increase smoking rates; and

3) overwhelm and severely harm the already-troubled FDA;

4) undermine the underlying mission of the FDA; and

5) make the federal government complicit with the tobacco companies in harming the public's health.

At the very least, the American public (and the constituents of the anti-smoking and health groups supporting the legislation) deserve a response to these criticisms.

At the very best, the health and anti-smoking groups should reverse their positions on this bill, go back to the drawing board, and collaborate on a truly effective and meaningful piece of legislation that would actually reduce, rather than increase, the use of the nation's most hazardous consumer product.

Wednesday, April 15, 2009

These Policies are Not a Win-Win-Win Proposition; They are Demonstrably Regressive, May Increase Health Disparities, and May Have a Disproportionate Negative Impact on the Poor

In the face of widespread budget crises and a severe recession, many state governments are considering the use of cigarette taxes as a primary means to raise much-needed revenue and to balance their budgets. But because smoking prevalence is higher among lower-income Americans and cigarette taxes therefore make up a more significant proportion of their income, there are concerns that cigarette taxes are regressive and may disproportionately harm the poorest of Americans.

This dilemma is highlighted in an article published last week in the Christian Science Monitor, which introduces the problem as follows: "High cigarette taxes curtail smoking and reduce the habit's societal costs. But they also take a big bite out of the earnings of America's poor, who smoke cigarettes at nearly twice the rate of the average American. That's the paradox of the new 62-cent federal tax on tobacco, a historic hike that puts the average pack of smokes at $4.80 – $3.10 of which is taxes. ... What differentiates this tax hike from previous efforts is that it's the largest one yet that doesn't contribute at least some funds to helping people quit. And it comes at a time when many cash-strapped states are cutting such programs."

In the article, one side of the issue is presented by Jim Sherman, a psychology professor at Indiana University: "...if you want to look at the impact on different segments of the population, you might want to consider who's going to be hit the most. And it's true that [regressive taxes like those on tobacco] hit lower-income populations the most."

The other side is presented by the Campaign for Tobacco-Free Kids, which argues that: "Most legislatures realize that it's a win-win-win. It's a win for health reasons, it's a win when it comes to state finances, and it's a win with the voters." In the article, the Campaign for Tobacco-Free Kids estimates that the recent federal cigarette tax increase will cause 1 million smokers to quit.

One possible justification for increased cigarette taxes despite its regressive nature is that if revenues are allocated specifically to help smokers (such as for cessation programs or for research into or treatment of smoking-related diseases), then the benefits as well as the costs of the tax accrue disproportionately to smokers, making the policy a fair one.

However, the recent federal cigarette tax increase and most of the proposed state cigarette tax increases are not slated to allocate revenue that will benefit smokers. The federal tax revenue is allocated entirely to children's health insurance and the state proposals allocate revenues for the purpose of balancing state budgets, not funding expanded tobacco cessation or smoking-related disease research and treatment programs. Thus, one of the major arguments that might otherwise justify these policies has been eliminated.

The remaining mainstay of anti-smoking groups' arguments in support of cigarette taxes, despite their regressive nature, is that although the tax weighs disproportionately on smokers, it will also affect their smoking behavior disproportionately, leading to increased quitting among lower-income smokers. In this way, the benefits of the tax increase accrue disproportionately to lower-income groups, thus negating the problem of the regressive nature of the tax.

For example, the Centers for Disease Control and Prevention is quoted in the article as arguing that: "When you take a look at poor smokers, yes, some of them will continue to smoke and carry a higher burden in taxes and price. But most of them will either quit or decrease the amount they smoke."

The Rest of the Story

Unfortunately, the arguments that lower-income smokers are more responsive to cigarette price increases and that a large proportion of these smokers will quit in the face of large price increases are largely based on data that are 20 years old, on cohorts of smokers in the past which are different from today's smokers, and on situations in which the underlying price of cigarettes was considerably lower than it is today. For example, many of these studies were conducted when cigarettes were in the range of $1.50 to $2.50 per pack, while the average price of a pack of cigarettes was reported as being $4.45 two years ago and is certainly well above $5.00 per pack today.

More recent studies that are based on more realistic and applicable price scenarios have found that the overall influence of price on cigarette smoking is considerably smaller than the assumptions being used by anti-smoking groups which are supporting these tax increases, that there is not credible evidence that these taxes affect lower-income smokers more than higher-income smokers, and that the primary effect of cigarette tax increases appears to be on lowering consumption, not stimulating smoking cessation.

For example, in a study published in the American Journal of Public Health in 2007, Franks et al. examined the relationship between cigarette price and smoking participation (smoking prevalence) both before and after the Master Settlement Agreement (MSA). The authors found that prior to the MSA, the price elasticity estimates were similar to those reported in the past and that lower-income groups were more sensitive to price increases. For lower-income groups, the price elasticity for smoking participation was -0.45 compared to -0.22 for higher-income groups. However, post-MSA, the price elasticity for smoking participation was not statistically significant for either group (-0.14 for low-income groups and -0.07 for higher-income groups).

The authors conclude that while in the past, cigarette price increases were associated with significant declines in smoking prevalence, that may not be true anymore: "Our findings, which are based on analyses of nationally representative data collected before and after the 1998 MSA, suggest a dramatic decline in the effect of cigarette pack prices on smoking participation in both lower and higher-income individuals. These findings, in turn, suggest that cigarette excise taxation may have become an ineffectual public health tobacco-control policy in the post-MSA era."

The authors also concluded that at the present time (as opposed to historically), increasing cigarette prices through taxation is a regressive measure that is likely to enhance income-based disparities in smoking prevalence: "The evidence suggests that increasing cigarette pack prices have not substantially contributed to reduction in disparities in smoking participation. Disparities may have increased as pack prices have increased. That the price of a product has risen despite an overall decline in demand for that product suggests that tobacco companies are responding, in part, to the demand from a remaining group of smokers who are price insensitive, probably because of addiction. This price-resistant group seems disproportionately concentrated among low-income persons. We believe that further significant increases in cigarette tax are likely to aggravate continuing inequities in our society, and through the economic burden associated with continued smoking participation of low-income persons, may result in other adverse health consequences."

An even more recent article published this year in the Journal of Health Economics revisited the issue of the price elasticity of demand for cigarettes among different education and income groups, using data from Canada, where cigarette prices were as high as six to seven dollars per pack. In this study, Gospodinov and Irvine found that there was no significant effect of cigarette price on smoking participation (i.e., smoking prevalence). They did find an effect on cigarette consumption, but the overall price elasticity of demand was -0.3 (lower than the level being assumed by anti-smoking groups from past data) and there was no evidence that lower-income or less educated smokers are more price sensitive than their counterparts.

These authors conclude: "Our primary conclusion is that there is little to suggest from our data that the traditional regressivity perspective on tobacco taxes can be overturned, and that there is therefore little hope that such tax increases may really benefit low socioeconomic groups, or disadvantage them to a lesser degree than high socioeconomic groups. In contrast to virtually all of the extant literature, our estimates are based on data where prices are closer to what might reasonably considered an ‘optimal’ range. ... On the policy front this suggests that the search for an implementable ‘optimal’ (i.e. very high) price for tobacco may simply not be feasible in most jurisdictions, and that once prices reach the $7–$8 range, alternative policy instruments such as smoking bans may provide more fruitful avenues of approach."

In a third recent article (2008) published in the Journal of Economics and Finance, Goel examines the influence of cigarette price on smoking participation overall and among various socioeconomic subgroups. He finds that price is not a significant determinant of smoking prevalence overall, and when examined by educational level, price was only significant for the most highly educated group (those with a college education), not for those with a high school or less than a high school education. Price was also not a significant predictor of smoking participation for either higher or lower-income groups. The authors conclude that: "non-price smoking policies are relatively more effective than price or tax policies and that these policies are becoming more effective as the population begins to age."

In a letter to the editor published in the American Journal of Public Health in 2008 entitled "Tobacco taxes and cigarette consumption in low income populations," David Ahrens of the Population Health Institute, University of Wisconsin, Madison argues that tobacco control groups should re-think their automatic support for increased cigarette taxes because the evidence shows that the primary effect of these taxes for the overwhelming majority of low-income cigarette smokers will be further impoverishment, rather than smoking cessation. Ahrens writes: "The Center for Tobacco Free Kids, an advocate of higher tobacco taxes, estimates that only 3% of the Master Settlement Agreement and tobacco excise taxes is used for tobacco control. Inclusion of the additional $7 billion from the federal excise tax would diminish the proportion spent on tobacco control to 2%. Furthermore, only a fraction of those funds are used to assist low-income smokers to help quit smoking. For tens of millions of smokers who want to quit, poorly funded tobacco control programs offer little assistance. Unfortunately, many of these same programs advocate for tobacco taxes under the misguided notion that high prices will economically coerce poor smokers to quit. If we are to believe our own science, that smoking is addictive, we must recognize the extent to which the primary result of highly priced tobacco products further impoverish a substantial portion of low-income tobacco users. This should be as much of a concern of public health advocates as the ongoing tobacco epidemic among the lower classes."

In light of these more recent data, I think anti-smoking groups need to rethink their knee-jerk support for policies by which cigarette tax increases are used to balance budgets and fund critical government programs that are not directly related to smoking. The underlying assumptions being used to justify these policies may no longer be true. It does not appear, for example, that lower-income smokers are more responsive to price increases than higher-income smokers. Nor does it appear that price increases will necessarily lead to substantial smoking cessation.

The reality is that for the majority of lower-income smokers, tax increases will result not in smoking cessation, but in continued smoking at a greater expense and at a higher proportion of overall income. This may have adverse consequences -- and even adverse health consequences -- and may be particularly problematic for the families and children of lower-income smokers, who may actually suffer as a result of these policies.

I should also hasten to point out that there are additional reasons why using cigarette tax increases to balance the federal and state budgets is poor public health policy. First, these policies make essential government programs dependent upon continued high levels of cigarette consumption for their solvency. Second, they create a financial partnership between the states or the federal government and Big Tobacco. Third, they reduce (if not eliminate) the incentive for Congress or state legislatures to enact any policy that would actually make a serious dent in smoking prevalence, because such policies would severely harm the budget, which (now) relies upon cigarette sales to fund its most essential programs and services.

I believe that anti-smoking groups should discontinue their support for any cigarette tax increases in which the revenues are not being allocated to directly benefit smokers - such as providing funding for smoking cessation programs, research into better treatments for smoking-related diseases, and treatment of smoking-related diseases.

Contrary to the long-standing dogma in the movement, these are not win-win-win propositions. There is a win, but unless the policy is properly crafted, that win comes at the expense of a number of losses: regressivity, lack of fairness, increased burdens upon lower-income populations, increasing health disparities, a government dependence upon continued cigarette consumption to fund critical programs, an unhealthy fiscal partnership between the states and Big Tobacco, and the elimination of any incentive to enact meaningful tobacco policies that would actually make a serious dent in smoking prevalence. The cigarette tax policies may actually be making it more difficult - if not impossible - for the more effective non-price policies to be implemented.

(Many thanks to David Ahrens of the Population Health Institute at the University of Wisconsin for providing data and critical insights that helped shape this commentary).

Tuesday, April 14, 2009

According its communications department, Washington University in St. Louis will ban smoking and tobacco use on its entire campus, including all outdoor property owned by the university (e.g., parking lots, sidewalks, streets, lawns, etc.) starting in July 2010. The purpose of the initiative is "to provide a healthy, comfortable and productive work and learning environment for students, faculty and staff."

Dr. Alan Glass, the assistant vice chancellor and director of the university's health and wellness center stated: "Smoke-free environments significantly reduce exposure to secondhand smoke, which has been associated with health problems such as heart disease and respiratory illnesses. This is an important campus health initiative, and the university will offer support to those affected in hopes of making the transition as easy as possible for our campus community."

He also stated: "We have much work to do, but when this initiative has been accomplished, we will have a healthier working and learning environment."

The Rest of the Story

If the real interest of Washington University was to create a healthier and safer environment for its students, then the first thing the university should do is not to ban tobacco use on the campus, but to eliminate alcohol use. While smoking on the campus causes few acute health problems, drinking on the campus causes a great deal of illness and injury and is a substantial threat to the health and safety of students.

A comprehensive review of the subject published in 2005 found that alcohol use among college students is the cause of more than 500,000 unintentional injuries and more than 600,000 assaults among college students each year (see: Hingson R, Heeren T, Winter M, Wechsler H. Magnitude of alcohol-related mortality and morbidity among U.S. college students ages 18-24: Changes from 1998 to 2001. Annual Review of Public Health 2005; 26:259-279).

In addition, approximately 2.8 million college students drive under the influence of alcohol and there are approximately 1700 annual alcohol-related deaths among college students.

I'm not arguing here that alcohol use should be banned on college campuses, but I am pointing out the inconsistency and hypocrisy of banning tobacco use in order to achieve a healthy campus but not eliminating alcohol use as well. Arguably, alcohol is a more important or at least more immediate threat to the safety, health, security, and well-being of college students.

Thus, if the university is truly interested in creating a safe and healthy environment and feels that banning all tobacco use on campus grounds is justified, it would also have to ban alcohol use in order to have any consistency or credibility.

The main argument the university is using to justify this policy is that it will protect members of the university community from exposure to secondhand smoke. That's fine, but what's required for that is not a complete ban on smoking, but simply a ban on smoking in university buildings and any outdoor locations where nonsmokers could not easily avoid exposure. Clearly, the purpose of a complete smoking ban has nothing to do with nonsmokers. It is an attempt to dictate the lifestyle choices being made by smokers. That too would be fine if all unhealthy lifestyle choices were being dictated by the university (or at least those lifestyle choices causing more than, or as much harm as smoking). But clearly, this is not the case, as alcohol - which causes many more serious and immediate problems and which also affects third parties -- is perfectly acceptable on campus.

It is this inconsistency and hypocrisy which leads me to believe that there has to be something more going on than simply a desire to create a healthy environment for the campus community. I leave it to my readers to tell me what that true underlying concern really is, because the argument that this is simply about creating a healthy campus environment just doesn't cut it for me.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.